ABLATE Versus PACE: PVI or AV Node Ablation and PM Implantation for Elderly Patients with Persistent AF

Launched by ST. JOSEFS-HOSPITAL WIESBADEN GMBH · May 27, 2021

Keywords

ClinConnect Summary

The ABLATE versus PACE trial is studying two different treatment options for older patients (75 years and older) who have persistent atrial fibrillation (AF), a heart condition that can cause irregular heartbeats. The trial compares the effectiveness of a procedure called pulmonary vein isolation (PVI) with a treatment that involves placing a pacemaker and performing AV node ablation. The goal is to see which method better reduces the chances of needing to go back to the hospital and improves the quality of life for these patients.

To be eligible for this trial, participants must have persistent AF that causes moderate to severe symptoms, even with standard medications. Key requirements include being at least 75 years old and able to provide written consent. However, individuals with certain health issues, such as heart valve disease or severe heart function problems, cannot participate. Those who join the trial can expect to receive either of the two treatments and will be monitored over time to assess their health outcomes and overall well-being. This study is currently recruiting participants, and it aims to provide valuable insights into the best approaches for managing atrial fibrillation in older adults.

Gender

ALL

Eligibility criteria

• Inclusion Criteria:
• • Persistent AF according to current ESC guideline (2020)
• • Symptoms EHRA classification II - IV despite guideline indicated medical therapy
• • Age ≥ 75 years
• • Capability of giving written informed consent
• Exclusion Criteria:
• • impaired systolic left ventricular function (ejection fraction \< 50%)
• • High-grade (III°) left cardiac valvular disease
• • pre-implanted pacemaker
• • bradycardia-indication for pacemaker
• • Surgical coronary revascularization (within the last 90 days) or current triple therapy after stent PCI
• • contraindication for PVI or pacemaker-implantation
• • contraindication for oral anticoagulation
• • body-mass-index BMI \> 40 kg/m2
• • inability to give written informed consent
• • concomitant participation in another registered trial
• • life expectancy \< 12 months
• • reversible cause of AF (e.g. thyrotoxicosis, alcohol ingestion)